Serum Calprotectin Level in Patients With Rheumatoid Arthritis and Osteoarthritis

December 16, 2019 updated by: Asmaa Nabil Badr, Assiut University
Assessment of the serum level of calprotectin in patients with rheumatoid arthritis and osteoarthritis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease with genetic susceptibility. It is characterized by chronic synovitis and progressive joint destruction. There is synovial infiltration by inflammatory cells, activation of synovial fibroblasts, and production of a wide range of inflammatory cytokines. Sustained high disease activity results in a poor disease outcome so assessment of inflammatory activity in RA is of pivotal importance for the optimal treatment in these patients. Disease activity of RA patients is assessed by clinical examination, laboratory tests and radiographic assessment (e.g. ultrasonography). Laboratory assessment of RA activity is done routinely by measuring acute phase reactants such as an erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), which are elevated in most patients with RA. It has been demonstrated that more than 40% of RA patients have normal ESR or CRP (false negative results). Therefore, new serum markers that can more accurately reflect real inflammatory activity in RA patients are needed. Calprotectin (CLP) is a calcium binding leucocyte protein consisting of the heterocomplex of S100A8/ A9 (myeloid-related protein, MRP8/MRP14), as well as being a major monocyte/macrophage protein which has gained interest as a marker of inflammation in RA. Calprotectin has been identified as an important endogenous alarmin, one of the damage-associated molecular pattern (DAMP) molecules that acts as a ligand for the TLR4 receptor and amplifies the inflammation cascade via NF-kB and p38 mitogen-activated protein kinase. Calprotectin levels are higher in the serum of RA patients compared with healthy subjects or patients with osteoarthritis (OA), Still, no cut-off levels have been identified to help in the diagnosis of RA. Calprotectin is involved in cartilage damage in OA. Synovial lining macrophages play a role in the OA process and in cartilage damage. Moderate calprotectin increase has been observed in the serum of OA patients compared with healthy controls also serum calprotectin levels were found higher in OA patients with synovial inflammation compared with those without.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult RA Patients who fulfilled the 2010 ACR/European league against rheumatism (EULAR) criteria for the classification of RA
  2. Adult osteoarthritis patients who fulfilled 2016 ACR revised Criteria for early diagnosis of knee OA

Exclusion Criteria:

  1. Individuals with other autoimmune diseases (systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, scleroderma, spondyloarthritis, behcet's disease, psoriasis and inflammatory bowel disease).
  2. RA patients with interstitial lung disease (IPF).
  3. Patients with malignancy.
  4. Patients with end stage organ failure.
  5. Other conditions that may affect the serum level of calprotectin as diabetes mellitus, coronary artery disease, hepatitis and concomitant inflammatory disease as acute infection or chronic inflammatory status.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: RA patients
A. Full history taking B. Physical examination C. Laboratory investigation: • Serum Calprotectin (CLP)
Other: serum calprotectin
serum calcium binding leucocyte protein
Other: OA patients
A. Full history taking B. Physical examination C. Laboratory investigation: • Serum Calprotectin (CLP)
Other: serum calprotectin
serum calcium binding leucocyte protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• Assessment of sensitivity and specificity of the serum calprotectin as an indicator of disease activity in both RA and OA patients.
Time Frame: a year
Analysis of serum level of calprotectin in both Rheumatoid arthritis and Osteoarthritis patients as an indicator of disease activity
a year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare between sensitivity and specificity of the serum calprotectin in detecting the activity of disease in both RA (Autoimmune inflammatory disease) and OA (Degenerative inflammatory disease)
Time Frame: a year
Compare between sensitivity and specificity of the serum calprotectin in detecting the activity of disease in both RA (Autoimmune inflammatory disease) and OA (Degenerative inflammatory disease)
a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mona Hussien Abd El-Samea, Dr., Assiut university hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

December 14, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (Actual)

December 17, 2019

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • calprotectin in RA and OA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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